MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5530-G-309
Medical Device Problem Codes	Degraded (1153); Fracture (1260); Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "revision of size 3 triathlon poly.Patient presented with pain, some clinical instability reported.Can¿t see item number or lot number to confirm poly size 3 no original operation info found.".
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding wear and crack/fracture involving triathlon insert was reported.The event was confirmed via evaluation of the returned device.Method & results: -device evaluation and results: visual inspection of the returned device indicated that the insert is worn and part of the articulating surface has cracked.The damage present is consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.A small portion of the posterior edge has fractured.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.-clinician review: no medical records were received for review with a clinical consultant.-device history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: visual inspection of the returned device indicated that the insert is worn and part of the articulating surface has cracked.The damage present is consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.A small portion of the posterior edge has fractured.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; +353 61498200
• MDR Report Key: 23830307
• Report Number: 0002249697-2025-01484
• Device Sequence Number: 5068206
• Product Code: MBH
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 5530-G-309
• Device Lot Number: MKHH3R
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female